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Improving Conduct and Feasibility of Clinical Trials to Evaluate Antibacterial Drugs to Treat Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Recommendations of the Clinical Trials Transformation Initiative Antibacterial Drug Development Project Team.
Knirsch C, Alemayehu D, Botgros R, Comic-Savic S, Friedland D, Holland TL, Merchant K, Noel GJ, Pelfrene E, Reith C, Santiago J, Tiernan R, Tenearts P, Goldsack JC, Fowler VG Jr. Knirsch C, et al. Among authors: goldsack jc. Clin Infect Dis. 2016 Aug 15;63 Suppl 2:S29-36. doi: 10.1093/cid/ciw258. Clin Infect Dis. 2016. PMID: 27481950
Use of Mobile Devices to Measure Outcomes in Clinical Research, 2010-2016: A Systematic Literature Review.
Perry B, Herrington W, Goldsack JC, Grandinetti CA, Vasisht KP, Landray MJ, Bataille L, DiCicco RA, Bradley C, Narayan A, Papadopoulos EJ, Sheth N, Skodacek K, Stem K, Strong TV, Walton MK, Corneli A. Perry B, et al. Among authors: goldsack jc. Digit Biomark. 2018 Jan 31;2(1):11-30. doi: 10.1159/000486347. eCollection 2018 Jan-Apr. Digit Biomark. 2018. PMID: 29938250 Free PMC article. Review.
FDA-Catalyst-Using FDA's Sentinel Initiative for large-scale pragmatic randomized trials: Approach and lessons learned during the planning phase of the first trial.
Cocoros NM, Pokorney SD, Haynes K, Garcia C, Al-Khalidi HR, Al-Khatib SM, Archdeacon P, Goldsack JC, Harkins T, Lin ND, Martin D, McCall D, Nair V, Parlett L, Temple R, McMahill-Walraven C, Granger CB, Platt R. Cocoros NM, et al. Among authors: goldsack jc. Clin Trials. 2019 Feb;16(1):90-97. doi: 10.1177/1740774518812776. Epub 2018 Nov 16. Clin Trials. 2019. PMID: 30445835
A systematic review of feasibility studies promoting the use of mobile technologies in clinical research.
Bakker JP, Goldsack JC, Clarke M, Coravos A, Geoghegan C, Godfrey A, Heasley MG, Karlin DR, Manta C, Peterson B, Ramirez E, Sheth N, Bruno A, Bullis E, Wareham K, Zimmerman N, Forrest A, Wood WA. Bakker JP, et al. Among authors: goldsack jc. NPJ Digit Med. 2019 Jun 6;2:47. doi: 10.1038/s41746-019-0125-x. eCollection 2019. NPJ Digit Med. 2019. PMID: 31304393 Free PMC article.
Advancing the Use of Mobile Technologies in Clinical Trials: Recommendations from the Clinical Trials Transformation Initiative.
Coran P, Goldsack JC, Grandinetti CA, Bakker JP, Bolognese M, Dorsey ER, Vasisht K, Amdur A, Dell C, Helfgott J, Kirchoff M, Miller CJ, Narayan A, Patel D, Peterson B, Ramirez E, Schiller D, Switzer T, Wing L, Forrest A, Doherty A. Coran P, et al. Among authors: goldsack jc. Digit Biomark. 2019 Nov 6;3(3):145-154. doi: 10.1159/000503957. eCollection 2019 Sep-Dec. Digit Biomark. 2019. PMID: 32095773 Free PMC article.
Considerations for development of an evidence dossier to support the use of mobile sensor technology for clinical outcome assessments in clinical trials.
Walton MK, Cappelleri JC, Byrom B, Goldsack JC, Eremenco S, Harris D, Potero E, Patel N, Flood E, Daumer M. Walton MK, et al. Among authors: goldsack jc. Contemp Clin Trials. 2020 Apr;91:105962. doi: 10.1016/j.cct.2020.105962. Epub 2020 Feb 20. Contemp Clin Trials. 2020. PMID: 32087341 Free article. Review.
Underuse of oral anticoagulants in privately insured patients with atrial fibrillation: A population being targeted by the IMplementation of a randomized controlled trial to imProve treatment with oral AntiCoagulanTs in patients with Atrial Fibrillation (IMPACT-AFib).
Al-Khatib SM, Pokorney SD, Al-Khalidi HR, Haynes K, Garcia C, Martin D, Goldsack JC, Harkins T, Cocoros NM, Lin ND, Lipowicz H, McCall D, Nair V, Parlett L, McMahill-Walraven CN, Platt R, Granger CB. Al-Khatib SM, et al. Among authors: goldsack jc. Am Heart J. 2020 Nov;229:110-117. doi: 10.1016/j.ahj.2020.07.012. Epub 2020 Jul 24. Am Heart J. 2020. PMID: 32949986 Free PMC article. Clinical Trial.
52 results